BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY

    MDR report key: 6474130 · Received April 7, 2017

    Report

    Report Number
    9614546-2017-00283
    Event Type
    Injury
    Date Received
    April 7, 2017
    Date of Event
    November 22, 2016
    Report Date
    May 11, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    POE
    UDI-DI
    05050474579064
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE INITIAL REPORT THE PRODUCT CODE WAS INCORRECTLY IDENTIFIED AS MFK. THE CORRECT CODE IS POE. DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. DEVICE INSPECTION COULD NOT BE PERFORMED, THEREFORE THE REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORDS WERE REVIEWED AND THE LENS WAS MANUFACTURED ACCORDING TO SPECIFICATION. A SEARCH ON COMPLAINTS REVEALED NO SIMILAR COMPLAINTS FOR THIS PRODUCTION ORDER NUMBER HAS BEEN RECEIVED. THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE INTRAOCULAR LENSES. BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE LENS REMAINS IMPLANTED. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    A PATIENT CALL TO REPORT HER EXPERIENCE FOLLOWING IMPLANT OF A SYMFONY INTRAOCULAR LENS (IOL) IMPLANTED (B)(6) 2016. THE LENS WAS IMPLANTED IN HER LEFT EYE. THE PATIENT COMPLAINED OF HAVING TO WEAR GLASSES FOR NEAR VISION. PATIENT WAS TOLD SHE WOULD BE SPECTACLE INDEPENDENT AND IS UPSET THAT SHE DOES NOT HAVE MULTIFOCAL VISION AT THIS TIME. PATIENT ALSO MENTIONED HER INTERMEDIATE VISION IS NOT GOOD AS WELL. ADDITIONALLY, WITH THE NEW LENS SHE SEES LESS TONES. PATIENT ALSO STATED SHE HAD A YAG PROCEDURE PERFORMED (B)(6) 2017, TO FIX A "WRINKLE". HOWEVER, THE PROCEDURE DID NOT IMPROVE HER VISION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252753 TECNIS SYMFONY MULTIFOCAL IOLS POE ABBOTT MEDICAL OPTICS ZXR00 05050474579064

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other